[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659176":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":18,"studyPopulation":22,"armGroups":18,"interventions":18,"overallOfficials":18,"centralContacts":18,"locations":18,"responsibleParty":23,"collaborators":18,"id":25,"slug":26,"hasResults":27,"nctId":28,"briefTitle":29,"officialTitle":30,"acronym":18,"eligibilityCriteria":31,"healthyVolunteers":32,"sex":33,"minAge":34,"maxAge":18,"enrollmentInfo":35,"targetDuration":18,"studyType":38,"phases":18,"briefSummary":39,"conditions":40,"keywords":18,"overallStatus":42,"whyStopped":18,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":18},{"fullName":5,"class":6},"Radiometer Medical ApS","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Analytical Performance of ABL90 FLEX PLUS Ki.","Analytical performance of the ABL90 FLEX PLUS Ki for pH, pCO₂, pO₂, cNa⁺, cK⁺, cCa²⁺, cCl-, cGlu, and cLac. Analytical performance will be assessed by:\n\n* agreement with the comparator method, evaluated by bias and corresponding 95% confidence intervals at predefined medical decision levels using regression analyses; and\n* repeatability, evaluated as standard deviation (SD) or coefficient of variation (CV), as applicable, with corresponding 95% confidence intervals.\n\nAnalyses will be performed separately for arterial and venous blood samples using data combined across study site.","6-8 month",[14],{"measure":15,"description":16,"timeFrame":17},"Additional Characterization of Analytical Performance of ABL90 FLEX PLUS Ki.","Additional characterization of analytical performance through site-specific analyses of bias and repeatability, and evaluation of the relationship between the ABL90 FLEX PLUS Ki and the comparator method using regression slope, corresponding 95% confidence intervals, and coefficient of determination (R²).","6-8 month.",null,{"allocation":18,"interventionModel":18,"interventionModelDescription":18,"primaryPurpose":18,"observationalModel":20,"timePerspective":21,"maskingInfo":18},"CASE_ONLY","CROSS_SECTIONAL","Adult in- and out-patients under standard of care to cover the reportable range of the parameters. Apparently healthy individuals may also provide samples through volunteer venipuncture to cover normal levels and for contriving.",{"type":24,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100659176","abl90-flex-plus-ki-mc-base-parameters-100659176",false,"NCT07860463","ABL90 FLEX PLUS Ki MC BASE Parameters","25009, ABL90 FLEX PLUS Ki Method Comparison Study for BASE Parameters in Whole Blood Samples","Inclusion Criteria:\n\n* The subject must be 18 years or older.\n* Informed consent obtained from subject able to understand information given and willing and able to voluntary give their consent to participate. Where the subject cannot provide informed consent, informed consent is obtained from the legally authorized\u002Fdesignated representative, once they have been fully informed.\n* For arterial and venous blood draw, the subject must have existing arterial and\u002For venous lines or undergo venipuncture as part of standard of care (criteria not appliable to apparently healthy individuals donating blood via venipuncture).\n\nExclusion Criteria:\n\n* Subjects who have previously provided successful measurements of arterial or venous samples for this study.\n* Subjects for whom the investigator (or designee) evaluates that sample collection would pose an unnecessary or unacceptable safety risk.",true,"ALL","18 Years",{"count":36,"type":37},300,"ESTIMATED","OBSERVATIONAL","The purpose is a Method Comparison Study on ABL90 FLEX PLUS for BASE Parameters in Whole Blood Samples.",[41],"Diagnostic Tests","NOT_YET_RECRUITING","2026-10-01",{"date":45,"type":46},"2026-10-06","ACTUAL",{"date":48,"type":37},"2027-01",{"date":50,"type":37},"2027-06",{"name":5,"class":6}]